The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

The project therefore has the following aims: 1) to characterize metabolic abnormalities and changes in body fat distribution, 2) to develop objective criteria for defining the syndrome and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the lipodystrophy syndrome in HIV-infected patients.

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Effect of drug regimens on adiposity overall and regional at year one and year two as compared to baseline

Effect of drug regimens on plasma glucose and insulin during OGTT at year one and two as compared with baseline

Effect of drug regimens on serum triglycerides and HDL cholesterol at year one and two as compared with baseline

Secondary Outcome Measures:

Multiple regression models will also be constructed to assess which factors in addition to PI therapy explain the variability in body fat changes, serum glucose, insulin and lipoproteins.

Estimated Enrollment:

200

Study Start Date:

February 2002

Study Completion Date:

October 2014

Primary Completion Date:

October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

A 2-year long prospective, randomized, double blind, placebo-controlled study in 200 asymptomatic HIV (+) patients to compare two equally effective antiretroviral regimens, one with and the other without a protease inhibiotor. We will study body fat distribution by anthropometry and magnetic resonance imaging and will measure insulin sensitivity (in a subset of patients), plasma lipoproteins, glucose tolerance and other metabolic variables. We will study expression of an array of adipocyte specific proteins/transcription factors involved in adipocyte differentiation, insulin action and lipoprotein metabolism in fat biopsy samples obtained before and after institution of therapy.

Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to conceive (defined as women taking oral contraceptives, using barrier protection during intercourse or with a copper intrauterine device in place for > 3 months without complaints and a negative serum or urine pregnancy test within 30 days of study entry).

Acute or chronic liver diseases; elevations of liver transaminases by more than two and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L, ) or a total bilirubin of > 1.5mg/dL.

Anemia (hematocrit <32%).

Abnormal thyroid function tests.

Weight loss >10% from baseline in the past year.

Recent (within the past year), history of suicide attempt.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00457665